| CTRI Number |
CTRI/2019/07/020014 [Registered on: 02/07/2019] Trial Registered Prospectively |
| Last Modified On: |
29/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the outcome in septic shock patients using central venous oxygen saturation values as predictor |
|
Scientific Title of Study
|
Central Venous Oxygen saturation as a mortality marker in septic shock-an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Mishra |
| Designation |
PG resident |
| Affiliation |
Pt. JNM Medical College, Raipur |
| Address |
Department of Anaesthesiology and critical care, Pt.J N M Medical College,RAIPUR(CG)
Raipur
CHHATTISGARH
492001
India |
| Phone |
9179893535 |
| Fax |
|
| Email |
draparnamishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr O P Sundrani |
| Designation |
Associate professor |
| Affiliation |
Pt J N M Medical College, Raipur |
| Address |
Department of Anaesthesiology and Critical Care, Pt. J N M Medical College, Raipur (CG)
Raipur
CHHATTISGARH
492001
India |
| Phone |
8103402828 |
| Fax |
|
| Email |
sundraniop@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr O P Sundrani |
| Designation |
Associate professor |
| Affiliation |
Pt J N M Medical College, Raipur |
| Address |
Department of Anaesthesiology and Critical Care, Pt. J N M Medical College, Raipur (CG)
Raipur
CHHATTISGARH
492001
India |
| Phone |
8103402828 |
| Fax |
|
| Email |
sundraniop@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B R A M HOSPITAL,RAIPUR,CHHATTISGARH |
|
|
Primary Sponsor
|
| Name |
Dr O P Sundrani |
| Address |
Department of Anaesthesiology and Critical Care, Pt J N M Medical College, Raipur, 492001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna Mishra |
Pt J NM Medical college and Dr. BRAM Hospital, Raipur, chhattisgarh |
Department of Anaesthesiology and Critical Care
Raipur
CHHATTISGARH |
9179893535
draparnamishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mortality marker in septic shock |
Measurement of central venous oxygen saturation and its relevance as a mortality marker in septic shock patients |
| Comparator Agent |
Mortality marker in septic shock |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients >18years of age admitted for management of septic shock at CCU of Dr. B R A M Hospital and Pt.J N M MEDICAL College, Raipur |
|
| ExclusionCriteria |
| Details |
Contraindication to CVC insertion, post CPR, systolic dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study mortality rate |
on admission then 2hours then 6hours then 28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study targets the patients with septic shock admitted in Critical Care Unit. Central venous oxygen saturation reflects the balance between global oxygen delivery and consumption.low value of central venous oxygen saturation are associated with mortality and its an easy tool to monitor resuscitative measures in septic shock patients. This study provides central venous oxygen saturation as a mortality marker which can be used to predict outcome in septic shock patients. |